A Pragmatic Randomized-Controlled Trial of a Digital Outreach Intervention for Lung Cancer Screening: mPATH-Lung (Mobile Patient Technology for Health-Lung)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26,998
- 试验地点
- 4
- 主要终点
- Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan
研究概览
简要总结
mPATH-Lung (mobile Patient Technology for Health - Lung) is an innovative digital outreach program that identifies patients who qualify for lung cancer screening and helps them get screened. The study will: 1) Determine the effect of mPATH-Lung on receipt of lung cancer screening in a pragmatic randomized-controlled trial conducted with primary care patients in two large health networks, 2) Elucidate the drivers of patients' screening decisions and screening behavior; and 3) Explore implementation outcomes that will impact the sustainability and dissemination of mPATH-Lung using program data, surveys, and interviews.
This project will determine how mPATH-Lung affects patients' screening decisions and their completion of screening.
详细描述
Primary Objective: Determine the effectiveness of mPATH-Lung on receipt of LCS in a randomized pragmatic clinical trial of 1318 patients recruited from two large health networks, Wake Forest Baptist Health and the University of North Carolina at Chapel Hill.
Secondary Objectives:
- Elucidate the drivers of patients' decisions to receive or forgo LCS through a values clarification exercise embedded within mPATH-Lung and supplemental semi-structured interviews of at least 50 patients.
- Assess several critical implementation outcomes (reach, acceptability, and appropriateness) to inform the sustainability and scalability of mPATH-Lung across diverse primary care settings
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meet the Medicare criteria for lung cancer screening, as updated in February 2022:
- •Age 50 - 77 years
- •Smoked at least 20 pack years
- •Current smoker or quit smoking within the past 15 years
- •Be scheduled to see a primary care provider within the health network in the next 3-4 weeks
- •Have a patient portal account or cellphone number listed in the electronic health record
排除标准
- •Patients flagged as needing a language interpreter in the electronic health record (electronic messages and intervention is delivered in English only).
- •Those for whom lung cancer screening would be inappropriate:
- •Prior history of lung cancer
- •Chest CT within the last 12 months
- •Those with medical conditions predicting shorter life expectancy
- •Patients whose home address is not within the state of North Carolina. (Due to telehealth guidelines)
结局指标
主要结局
Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan
时间窗: Within 16 weeks of enrollment
Participants who have completed any chest CT within 16 weeks of study randomization, as determined by electronic health record review
次要结局
- Proportion of Patients With LCS Scans Ordered(16 weeks)
- LCS Screening Decision(Up to 16 weeks after day of enrollment)
- Proportion of Patients With LCS Clinic Visits Scheduled(16 weeks)
- Proportion of Patients With LCS Clinic Visits Completed(16 weeks)
- LCS Clinic Referral Requested Through mPATH(16 weeks)
- Lung Cancer Screening Test Results(16 weeks)
- Number of LCS False Positives(1 year)
- Invasive Procedures Following LCS Scan(1 year)
- Proportion of Patients With Complications Following LCS(1 year)
- Number of Diagnosed Lung Cancers(16 months after randomization)
- How Diagnosed Lung Cancers Were Detected(16 months after randomization)
- Stage of Lung Cancers Diagnosed(16 months after randomization)
- Overscreening(1 year)
- Reach of Digital Outreach Strategy(16 weeks)
- Completion of mPATH-Lung Program(16 weeks)